When a drug is developed, the company that owns the patent retains control over who can make or sell it. But this patent has an expiration date and, when it expires, other companies can develop a generic product with the same active ingredient – and market it at a more affordable price. This happens with biological medicines as well, but as they are much more complex than conventional chemical medicines, it is not possible to develop an identical product. This “generic” version of a biological, therefore, is called a biosimilar medicine.

Although not identical to the original biological medicine, the biosimilar does not lose anything in quality, safety and efficacy and, at the same time, it manages to be produced at lower costs, which makes it more accessible to patients. This encourages competition in the marketplace, which tends to lower not only the final price of the product, but also the production costs – both of biosimilars and original biologicals – providing easier access to this type of medicine.

Approval process for biosimilar medicines

As it is not possible to produce a biosimilar identical to the original biological, this type of drug undergoes a rigorous approval system by ANVISA (National Health Surveillance Agency), which includes the following studies:

• Quality comparisons, clinical and non-clinical: the objective of these studies, in addition to showing the similarities between the biosimilar medicine and the reference biological medicine, is to show that any differences between them will not have an impact on the quality and safety of the product;
• Non-comparative: when the drug is produced from a new biotechnology process, quality data, clinical and non-clinical studies are required according to existing knowledge of the reference biological;
• Equivalence or non-inferiority study: must demonstrate that the biosimilar is as effective as the reference drug, in relation to expected clinical outcomes. If not, the difference must be within pre-established limits – otherwise, the drug is disapproved by ANVISA.

The amount of data requested varies according to the type of drug submitted for analysis, but studies on biosimilars are usually shorter and smaller than those on reference biologicals.

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